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Implant for Augmentation of Cerebral Blood Flow Trial, Effectiveness and Safety in a 24 Hour Window (ImpACT-24)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by BrainsGate
Sponsor:
Information provided by (Responsible Party):
BrainsGate
ClinicalTrials.gov Identifier:
NCT00826059
First received: January 19, 2009
Last updated: September 2, 2015
Last verified: September 2015

January 19, 2009
September 2, 2015
January 2009
November 2017   (final data collection date for primary outcome measure)
Distribution of patients across the ordinal modified Rankin scale (mRS) [ Time Frame: 90 days ] [ Designated as safety issue: No ]

The primary effectiveness endpoint will be the modified Rankin Scale (mRS) evaluated by the site on Day 90±7.

The statistical analysis of the primary effectiveness endpoint will be: Sliding Dichotomous mRS.

  • Distribution of patients across the ordinal modified Rankin scale (mRS) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Safety measurements across all study population [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00826059 on ClinicalTrials.gov Archive Site
  • Sliding Dichotomous mRS for subjects with aphasia at baseline [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Binary NIHSS (success for score ≤ 1 or for ≥ 9-point improvement versus baseline) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Binary NIHSS [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Dichotomous mRS [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Implant for Augmentation of Cerebral Blood Flow Trial, Effectiveness and Safety in a 24 Hour Window
A Multicenter, Randomized, Double Blind, Sham Control, Parallel Arm Trial to Assess Effectiveness and Safety of the Ischemic Stroke System ISS, as an Adjunct to Standard of Care in Subjects With Acute Ischemic Stroke
The primary objective of the study is to assess the safety and effectiveness of SPG stimulation with the ISS in patients with an acute ischemic stroke in the anterior circulation initiated within 24 hours from stroke onset.

A multi-center, multinational, randomized, double blind, sham control, adjunctive to Standard of Care, parallel arm study and will include ongoing DSMB review of accumulated safety data.

Screening:

Since the treatment should be initiated within 24 hours from stroke onset, the screening window is limited and all procedures should be performed within this window.Subjects with Acute Ischemic Stroke will be screened upon arrival to the hospital. Since the treatment should be initiated between 8 and 24 hours from stroke onset, the screening window is limited and all procedures should be performed as soon as possible. All screened patients will be identified by patient number and will sign the informed consent prior to any study procedure initiation.

Period 1: Day 1-5

: Day 1- Eligible subjects will be randomized in a 1:1 (ISS Stimulation: Sham Control) ratio:

  • Group 1: Implantation and ISS Stimulation during five consecutive days & Standard of Care
  • Group 2: Sham Implantation and Sham Stimulation during five consecutive days & Standard of Care Subjects will be transferred to the implantation procedure facility and the implantation/sham implantation will be performed by a trained physician.

Following implantation, stimulation/sham stimulation will be delivered. Day 2-4 ISS / Sham Stimulation will be repeated during the following four consecutive days by trained personnel within 18-26 hours from preceding stimulation.

Day 5 / Day of Discharge. Following the last ISS /Sham Stimulation, explantation will be performed and the patients will be evaluated for safety and effectiveness.

Subjects will continue with Standard of Care as needed and will be released from the hospital upon investigator's judgment.

Period 2: Day of Discharge - 89±7 days During this period both groups (ISS Stimulation and Sham Control) will be treated according to Standard of Care either at the hospital, rehabilitation center or at home.

Scheduled visits will be performed on day 30±7 and day 60 ±7, which will include safety and effectiveness assessments.

Final Visit Day 90±7 days: The final visit will be performed at the study site and will include safety and effectiveness evaluations.

Patients will be contacted by study personnel via telephone on Day 180±7 and on Day 360±7 in order to assess their quality of life status.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Ischemic Stroke
  • Device: The Ischemic Stroke System
    SPG stimulation and standard of care
  • Device: Sham control
    Sham stimulation and standard of care
  • Experimental: Active Stimulation
    Implantation and ISS Stimulation during five consecutive days & Standard of Care
    Intervention: Device: The Ischemic Stroke System
  • Sham Comparator: Sham Stimulation
    Sham Implantation and Sham Stimulation during five consecutive days & Standard of Care
    Intervention: Device: Sham control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
November 2017
November 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age: Between 40 years and 80 years for male and 85 for female subjects
  2. Clinical diagnosis of an acute ischemic stroke in the Carotid, Middle or Anterior Cerebral Artery territories
  3. Imaging findings demonstrating signs of ischemia in the anterior circulation, consistent with the clinical diagnosis
  4. Baseline NIHSS ≥ 7 and ≤ 18 within 2 hours prior to implantation.
  5. Ability to initiate treatment within 8- 24 hours from stroke onset
  6. Signed informed consent from patient him/herself or legally authorized representative if applicable

Exclusion Criteria:

  1. Intracranial hemorrhage or hemorrhagic transformation
  2. Massive stroke
  3. Acute ischemic stroke in the posterior circulation
  4. Minor stroke
  5. Treated with IV-tPA ,IA-tPA or neurothrombectomy devices for the current stroke
  6. Previous stroke in the last 6 months or pre-existing disability
  7. Patients with bleeding propensity or any condition in the oral cavity that prevents implantation
  8. Clinical signs and symptoms or imaging evidence of bilateral stroke.
  9. Treated with IV-tPA ,IA-tPA or neurothrombectomy devices for the current stroke.
  10. Known cerebral arteriovenous malformation, cerebral aneurysm.
  11. Clinical suspicion of septic embolus.
  12. Uncontrolled hypertension (systolic >185 mmHg and/or diastolic >110 mmHg)
  13. Serious systemic infection.
  14. Women known to be pregnant or having a positive or indeterminate pregnancy test.
  15. Patients with other implanted neural stimulator/ electronic devices (pacemakers).
  16. Life expectancy < 1 year from causes other than stroke.
Both
40 Years to 85 Years   (Adult, Senior)
No
Contact: Eyal Ozeri 972 4 637 7774 eyalo@brainsgate.com
United States,   Germany,   Spain
 
NCT00826059
CLP1000500
Yes
Not Provided
Not Provided
BrainsGate
BrainsGate
Not Provided
Study Director: Eyal Shay BrainsGate
BrainsGate
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP